CurrentMass General Brigham Health PlanPolicy N/A

Obizur (antihemophilic factor [recombinant], porcine sequence) — Prior authorization (Pharmacy Benefit)

Prior authorization policy governing pharmacy benefit coverage of Obizur for Commercial/Exchange members; specialty pharmacy fill required. Applies to use in adults with acquired hemophilia A.

Policy Summary

PayerMass General Brigham Health Plan

PolicyObizur (antihemophilic factor [recombinant], porcine sequence) — Prior authorization (Pharmacy Benefit)

Policy CodePolicy N/A

Change TypeClarified benefit assignment (medical → pharmacy)

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization requests under the pharmacy benefit with documentation of indication, prescriber specialty or hematology consultation, and baseline anti-porcine FVIII inhibitor titer (≤ 20 BU); approvals are typically for 1 month.

SourceLink

POLICY UPDATE CHANGES

Policy updated to indicate it no longer applies to the medical benefit and is under the pharmacy benefit effective 01/01/2026.

1Typical approval duration

AdultsIndication covered

>20 BUExclusion threshold (titer)

SpecialtyDispensing limitation

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Initial Authorization — Covered when ALL of the following are met

Authorization may be granted when the following criteria is met:

ALL of the following

Requested medication is prescribed for the treatment of acquired hemophilia A
Requested medication is prescribed by or in consultation with a hematologist
Member is an adult (Obizur indication is for adults)
Member does not have hemophilia A with inhibitors (Obizur is contraindicated in this population)
Contraindication — do not approve if hemophilia A with inhibitors
Member does not have baseline anti-porcine FVIII inhibitor titer greater than 20 Bethesda Units (BU)<= 20 BU
Safety/efficacy not established with baseline titer >20 BU

New-to-Plan Members

Authorization may be granted for members new to the plan within the past 90 days under specific circumstances:

ALL of the following

Member is new to the plan within the past 90 days
Member is currently receiving treatment with the requested medication
Excludes cases where product was obtained as samples or via manufacturer's patient assistance programs

Continuation (Reauthorization) — Covered when ALL of the following are met

Requests for reauthorization will be approved when the following criteria are met:

ALL of the following

Initial criteria are met

What Providers Must Do

Prior Authorization

Prior authorization required

Prior authorization is required for Obizur under the pharmacy benefit for Commercial/Exchange members; approvals are typically granted for 1 month.

Documentation Required

Prescriber specialty and indication documentation

Document that Obizur is prescribed for acquired hemophilia A and that the prescriber is a hematologist or that care is provided in consultation with a hematologist.

Documentation Required

Lab documentation for anti-porcine FVIII inhibitor titer

Provide baseline laboratory documentation of the anti-porcine factor VIII inhibitor titer demonstrating a value ≤ 20 BU; safety and efficacy are not established if the baseline titer is > 20 BU.

Denial Risk

Excluded uses / contraindications

Requests for Obizur for von Willebrand disease, for hemophilia A with inhibitors, or for other non–FDA‑approved indications are considered experimental/investigational or contraindicated and will not be approved.

Not indicated for von Willebrand disease (Limitations of Use B).
Contraindicated in patients with hemophilia A with inhibitors (Limitations of Use C).
All other indications are considered experimental/investigational and not medically necessary.

Billing Rule

Specialty pharmacy dispensing

This medication has been designated specialty and must be filled at a contracted specialty pharmacy in accordance with the specialty limitations.

Clinical Background

Obizur (antihemophilic factor [recombinant], porcine sequence) is a recombinant porcine-sequence factor VIII product indicated for the on-demand treatment and control of bleeding episodes in adults with acquired hemophilia A. The product is covered under the pharmacy benefit for Commercial/Exchange members and has been designated a specialty medication that must be dispensed through a contracted specialty pharmacy (effective 01/01/2026).

Use of Obizur has important limitations: safety and efficacy have not been established in patients with a baseline anti-porcine factor VIII inhibitor titer greater than 20 BU; Obizur is not indicated for the treatment of von Willebrand disease; and it is contraindicated in patients with congenital hemophilia A with inhibitors. These limitations and the change in benefit applicability were documented in the policy review history (updated 10/08/2025; effective 01/01/2026).

Policy Changes

2023-12-13administrative_change

Reviewed at December P&T; formulary source switched from SGM to Custom, effective 2024-01-01.

2025-05-14review

Reviewed at May P&T; no criteria changes, with changes effective 2025-06-01.

2025-10-08benefit_assignment_updateLatest

Reviewed at October P&T; policy updated to indicate it no longer applies to the medical benefit and is assigned to the pharmacy benefit effective 2026-01-01.

Policy Summary

PayerMass General Brigham Health Plan

PolicyObizur (antihemophilic factor [recombinant], porcine sequence) — Prior authorization (Pharmacy Benefit)

Policy CodePolicy N/A

Change TypeClarified benefit assignment (medical → pharmacy)

Effective DateJan 1, 2026

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Obizur (antihemophilic factor [recombinant], porcine sequence) — Prior authorization (Pharmacy Benefit)

Authorization Criteria for Obizur

What Providers Must Do

Policy Coding Context

Clinical Thresholds and Typical Approval Metrics

Clinical Background

Defined Terms

Policy Changes